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Home > "I" Clinical Trials Conditions > Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases  Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases
Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases
For Condition: lung metastases,Small Cell Lung Cancer,Non-small cell lung cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients who have primary lung cancer or lung metastases.
Details: OBJECTIVES: - Determine the maximum tolerated dose and phase II dose of inhaled doxorubicin administered every 3 weeks in patients with primary lung cancer or cancer metastatic to the lung. - Determine the toxic effects and pharmacokinetic profile of this regimen in this patient population. - Examine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients. - Obtain preliminary evidence of therapeutic activity of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive inhaled doxorubicin every 3 weeks. Treatment continues for a maximum of 3 courses in the absence of unacceptable toxicity or disease progression. Patients may reenter at a higher dose level after a 3-month waiting period. Cohorts of 3-6 patients receive escalating doses of doxorubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 6 weeks. PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary lung cancer or cancer metastatic to the lung that is not potentially curable by standard chemotherapy, radiotherapy, or surgery - Bronchoalveolar cell lung cancer allowed - Lung metastases from soft tissue sarcoma allowed - No leukemia or lymphoma PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 4,000/mm^3 - Platelet count at least 160,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin no greater than 1.0 mg/dL - AST/ALT less than 1.5 times upper limit of normal Renal: - Creatinine no greater than 1.2 mg/dL OR - Creatinine clearance at least 50 mL/min Cardiovascular: - LVEF normal by MUGA scan or echocardiography - No unstable angina - No congestive heart failure - No symptomatic arrhythmias Pulmonary: - DLCO at least 65% of normal - FVC at least 50% predicted - FEV1 at least 50% predicted - Resting oxygen saturation at least 90% - Exercise oxygen saturation at least 85% - No complete atelectasis - No asthma Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study - No congenital problems (e.g., cleft palate) or other anomalies that would prevent tight fit of mouth seal - No other concurrent illness that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior chemotherapy and recovered - No prior bleomycin or nitrosoureas - No prior mitomycin greater than 25 mg/m^2 - No prior anthracyclines greater than 450 mg/m^2 - No other concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 3 weeks since prior radiotherapy and recovered - No prior chest (pulmonary or mediastinal) or thoracic spine radiotherapy - Patients with only chest wall or primary breast radiation are eligible - No concurrent thoracic irradiation Surgery: - See Disease Characteristics - No prior pneumonectomy Other: - No daily or as necessary respiratory drugs via inhaler or nebulizer - No other concurrent experimental drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NaiyerRizvi, Study Chair, Memorial Sloan-Kettering Cancer Center
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210
United States
Recruiting Gregory Otterson 614-293-6786
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting David Kelsen 212-639-2428
Additional Information:
Study ID Numbers: CDR0000067614; MSKCC-99049,BMI-98-DOX-001,NCI-G00-1696
Study Start Date:
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004930
Other Lung Metastases Studies:
1. Conventional or Video-Assisted Surgery in Treating Patients With Lung Metastases
2. Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma
3. Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
4. Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
5. Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung
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Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases
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